At Natural Bio Health, our physicians have been treating men with testosterone for more than fourteen 14 years. We have four medical clinics located in Austin, College Station, San Antonio and Odessa, Texas and have treated thousands of men with testosterone therapy. Therefore, we were somewhat taken aback by the recently published VA study of older, at risk men, that warned that the testosterone users in this particular cohort (group) of men “had a higher incidence of  ischemic stroke, a heart attack or to have died of any cause.”

http://jama.jamanetwork.com/article.aspx?articleid=1764051. November 6, 2013. Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels.

This report made headlines in the LA Times with the following comment from a reporter:

The new research found that among 8,709 older men who were assessed for the possibility of blocked arteries, those taking testosterone were 30% more likely to suffer an adverse event — a stroke, a heart attack or death. Melissa Healy, LA Times, November 5, 2013, 1:24 p.m.

http://www.latimes.com/science/sciencenow/la-sci-heart-disease-testosterone-replacement-20131105,0,3592717.story.

Mike Clark's response to the JAMA study: Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels .Cautionary warning to all men taking testosterone or unnecessary scare?

Should all men taking testosterone or who are considering taking testosterone now fear an increased risk of dying, heart attack or stroke? Or, should just men in a certain age category with significant health conditions take caution before taking testosterone therapy? Or, should this study, like the Women’s Health Initiative Study, be scrutinized for misleading the public with flawed facts and misinterpreted data?

The answer: This new study should act as a cautionary warning to men with significant health conditions that taking testosterone (or testosterone boosters sold by supplement stores like GNC or steroid shops) might have an adverse effect on their health. It should also act as a cautionary warning to men seeking testosterone therapy from unqualified clinics that are popping up around the country marketing testosterone without any serious consideration of the health of their clients.

However, all men should also know that testosterone has incredible and substantiated health benefits for men when properly prescribed and monitored. It should not be feared but welcomed by men as an adjunct to a healthy and fulfilling life. See a few of the many studies below showing the heart benefits of testosterone. Call Natural Bio Health in Austin, Odessa, San Antonio or College Station for studies. For information go to www.naturalbiohealth.com.

The Proof is in the man (and the medical clinic). The professionals at Natural Bio Health can personally attest to the benefits of long term testosterone use. The author of this blog (me) is 67 years of age and has been taking testosterone for more than 14 years.  My health is great, I exercise regularly and all of my blood tests are in the optimal range, in part due to taking bioidentical hormones including testosterone. My wife Sandy has also been taking testosterone for 14 years and is in great health (yes women benefit from testosterone also). We take no statin drugs, no diabetic drugs, no anti-depressants, no sleep medications, no hypertension drugs or any other such drugs.

Dr. Joseph Feste, a physician with Natural Bio Health, is 78 years of age and has been taking testosterone for several years as has his wife. He is in great health and actively practices medicine 5 days a week and is often researching during the weekends. Dr. David Weiler, another physician for Natural Bio Health, is 66 and has been taking testosterone for years. He too is in great health. We are all older than the men in the VA study.

We have men (and women) on our programs who have been with us for 14 years, taking testosterone and other bioidentical hormones and enjoying a great quality of life. We have men and women of all age groups who were found to be testosterone deficient and now enjoy a healthy fulfilling life with hormone therapy including testosterone. There are thousands of other men and women across the United States enjoying the benefits of testosterone who are being treated by experienced, professional doctors.

False reporting? Miscalculation? There is an old saying that “figures don’t lie but liars figure.” In this case, we have to wonder not about liars but how the calculations were made that came to the conclusion in the published study that:

“In the three-year period they were followed, 25.7% of the men taking testosterone supplementation had suffered a stroke, a heart attack or death. Among the men who did not take testosterone, 19.9% suffered one of those outcomes. Of 7486 patients not receiving testosterone therapy, 681 died, 420 had MIs, and 486 had strokes. Among 1223 patients receiving testosterone therapy, 67 died, 23 had MIs, and 33 had strokes.”

Do your own calculations and then ask how and why the VA study came up with their numbers. We come up with vastly different numbers. 

Using the data provided in the VA study, Dr. Joseph Feste of Natural Bio Health calculated that 21.19 % of the men who did not take testosterone had events while only 10% of the men who took testosterone had events. This is directly contrary to the VA study as published by JAMA. Dr. Feste has written to the editorial board of JAMA and asked them to correct their numbers.

My calculations (feel free to test them): Using the VA study numbers are shown in the chart below, I come to a different set of numbers. The numbers based on the data provided are as follows:

  • NOT using testosterone, 9.1% died. Using testosterone, 5.4% of the men died.
  • NOT using testosterone, 5.6% had MIs. Using testosterone, 1.9% of the men had MIs.
  • NOT using testosterone, 6.5% has strokes. Using testosterone, 2.7% of the men had strokes.
Total % of total Event/Classification
7486 86% No testosterone therapy
681 9.1% Men died
420 5.6% Had MIs
486 6.5% Had strokes
1223 14% Testosterone therapy
67 5.5% Men died
23 1.9% Had MIs
33 2.7% Had strokes

 Even in this study, it looks to me as if the men using testosterone did better.

So where did the LA Times reporter get her number that “those taking testosterone were 30% more likely to suffer an adverse event — a stroke, a heart attack or death”? We will ask her but it is not supported by our math calculations. It does make good headlines however.

So do we ignore any and all warnings about the use of testosterone? NO!

Testosterone is a hormone that acts upon the body in many different ways. It is highest when we are young and continually declines over the years. In our experience, most men over the age of 30 have suboptimal levels of free testosterone and have matching symptoms. The men in the quoted study had several health issues before commencing testosterone therapy.

“Approximately 20% of the men in the study had a prior history of MI, 50% had diabetes, and more than 80% had CAD. Of the 8709 patients, 1223 (14.0%) initiated testosterone therapy after a median of 531 days (interquartile range [IQR], 229-894 days) following angiography”

The study did not say how many of the testosterone therapy group had diabetes or were obese or had CAD but 80% of the veterans already had CAD. Coronary artery disease (CAD) is the most common type of heart disease. It is the leading cause of death in the United States in both men and women. CAD happens when the arteries that supply blood to heart muscle become hardened and narrowed. This is due to the buildup of cholesterol and other material, called plaque, on their inner arterial walls.

Many men are taking testosterone without regards to any health issue they may have that should also be addressed and monitored while on testosterone therapy. Hormones are chemical messengers in the body that should be prescribed by competent and experienced physicians. They should not be prescribed by clinics who do minimal testing and ignore such conditions as diabetes, hypertension, existing heart conditions, high cholesterol, etc. Testosterone can BETTER these conditions in the hands of qualified physicians.

Conditions of the study that make us pause as to its validity.

We have already questioned the numbers that were used to conclude an increased risk of “events” in men who use testosterone. Other aspects of the study make us question its overall findings and conclusions (while still giving credit to its underlying warnings).

We have found that hormones are best used in a preventive role. They can be used in conjunction with diet and exercise, stress reduction, and stress management to even reverse certain disease processes. However, testosterone, like other bioidentical hormones are not a magic cure all. Men and women must eat properly, exercise regularly and address all and any pre-existing condition to ensure their health and longevity.

Pre-existing conditions. The veterans studied by the VA “initiated testosterone therapy after a median of 531 days (interquartile range [IQR], 229-894 days) following angiography.” Many had serious health conditions. Not only did they wait a long time to initiate therapy, but 80% already had CAD and another 50% had diabetes. Between 85% and 90% had high blood pressure or worrisome cholesterol readings. Almost 6 in 10 showed signs that plaque was obstructing the arteries feeding blood to their hearts.

Patients excluded from the study: Men who started testosterone therapy prior to coronary angiography were excluded so the VA did not track these men. Additionally, patients who started testosterone therapy prior to having a testosterone level checked in the VA were excluded “because we did not know if the patient had low testosterone levels prior to treatment.” [In our testing of thousands of men, almost all men over the age of 30 have low testosterone.] Also excluded were patients with missing coronary anatomy data and those who were prescribed testosterone therapy after an MI. Apparently, no one tracked these men who might have benefited the most from “proper” testosterone therapy.

Treatment plan and method – RIDICULOUS? According to the published study, “Patients were categorized as initiating testosterone therapy if they filled a prescription for testosterone gel, patch, or injections following coronary angiography based on pharmacy-dispensing data (VHA Decision Support System). Once initiated, a patient was assumed to have continued treatment until an outcome event occurred or the end of follow-up.

This means that the study was based on an ASSUMPTION that the men were compliant and continued taking testosterone.

The study stated that of the patients receiving testosterone therapy, “13 (1.1%) were prescribed testosterone gel; 436 (35.7%), injections; and 774 (63.3%), patches. The most common gel dispensed was testosterone 1% 5-g packets; injections, testosterone 200-mg/mL injections; and patch testosterone, 2.5-mg/24-hour patch.” We have not found any of these particularly useful except for the testosterone injections and then when injected once or twice a week while monitoring cholesterol, blood platelets and estradiol as a minimum.

Another astounding fact:

“Of the 1223 patients prescribed testosterone therapy, 215 patients (17.6%) filled only 1 prescription and 1008 (82.4%) filled more than 1 prescription for testosterone therapy. Of the patients with more than 1 filled prescription, the mean number of days from first fill to the last fill of testosterone therapy was 376 days. Furthermore, the mean numbers of refills by testosterone formulation were 9.8 for gel, 11.2 for injections, and 6 for patches. Of the patients prescribed testosterone therapy, 734 patients (60.0%) had another testosterone value checked after starting treatment…. Among these patients, the baseline testosterone level was 175.5 ng/dL and increased to 332.2 ng/dL for the first repeat testosterone measurement.” [Emphasis added.]

 What is astounding was that this study is actually being given credit when, “a patient was assumed to have continued treatment until an outcome event occurred or the end of follow-up” and of those tested, the baseline only increased to another very low level. Obviously, whatever testosterone treatment was being given was not working much!

 Where do we go from here? Go to a qualified clinic with experienced physicians who treat all aspects of your health and test accordingly. Then receive all of the well documented benefits of testosterone and other bioidentical hormones.

A few studies. Hundreds are available showing the benefits of testosterone.

Men with CAD had significantly lower

– Total Testosterone

– Free Testosterone

– Bioavailable Testosterone

English K et al. Men with coronary artery disease have lower levels of androgens than men with normal coronary angiograms. Eur Heart J 2000 Jun;21(11):890-4.

Acute administration of high-dose testosterone in men with coronary artery disease improves endothelial function. Ong PJ et al. Testosterone enhances flow-mediated brachial artery reactivity in men with coronary artery disease. Am J Cardiol 2000 Jan 15;85(2):269-72.

 Intracoronary injection of T at men with established CAD

• Coronary artery dilation

• Increased coronary blood flow

Webb CM et al. Effects of testosterone on coronary vasomotor regulation in men with coronary heart disease. Circulation 1999 Oct 19;100(16):1690-6.

 

Mike Clark, Ph.D., Director of Education & Research

Diplomate of Anti-Aging Medicine,  Brain Fitness Certification

Fellow of Anti-Aging, Regenerative and Functional Medicine

Tel: 512-266-6713

Fax: 512-266-6714

[email protected]